3 Animal cloning
| (a)
(35688)
18152/13
+ ADDs 1-2
COM(13) 892
(b)
(35689)
18153/13
COM(13) 893
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Draft Directive on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes
Draft Council Directive on the placing on the market of food from animal clones
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| Legal base
| (a) Article 43(2) TFEU; c o-decision; QMV
(b) Article 352(1); consent; unanimity
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| Document originated
| 18 December 2013
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| Deposited in Parliament
| 31 December 2013
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| Department
| Environment, Food and Rural Affairs
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| Basis of consideration
| EM of 14 January 2014
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| Previous Committee Report
| None; but see footnote 23
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| Discussion in Council
| No date set
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| Committee's assessment
| Legally and politically important
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| Committee's decision
| Not cleared; further information requested
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Background
3.1 Cloning[22]
is a relatively new breeding technique which allows for the asexual
reproduction of animals which have shown good productivity, low
incidence of disease and the ability to cope with the production
environment, and has been the subject of extensive discussion
within the EU. In particular, the Commission produced in October
2010 a report[23] which
sought to assess the technology as it applies to food production,
looking at such aspects as food safety and the health and welfare
of the animals, as well as the ethical and trade implications
and the rights of consumers.
3.2 It concluded that, whilst it is
scientifically accepted that there are no food safety concerns
about food produced from clones or their offspring, the animal
welfare[24] risks provide
a solid basis for it to initiate legislation. After identifying
a range of options — including preserving the legal status
quo; a total prohibition on the cloning of farm animals for food
on EU territory, on the use of clones and on the placing on the
market of food from them, including imports; on the placing on
the market of the offspring of clones and food arising from such
offspring, and on the use of reproductive material from clones
— it said that it would propose to:
· suspend temporarily the use
of the technique in the EU for the reproduction of all food producing
animals, the use of clones of these animals, and the marketing
of food from clones; and
· establish the traceability
of imports of semen and embryos to allow farmers and industry
to set up data banks of offspring in the EU.
3.3 It adds that the measure would be
based subject to review after five years, and that cloning would
remain possible for all purposes other than food production (such
as research, the production of pharmaceuticals, and the conservation
of endangered species or breeds).
3.4 As we noted in our Report of 24
November 2010, the Government recognises that cloning is not a
traditional breeding technique, and the need to safeguard food
safety and consumer choice (for example, by approval having to
be sought under the Novel Foods Regulation (258/97) before food
from clones themselves can be marketed). However, whilst also
recognising that the welfare of clones and their surrogate dams
needs to be protected, it believes that existing EU legislation
is sufficient to deal with welfare issues. In particular, it was
opposed to a ban, or temporary prohibition, on cloning, the use
of clones and the marketing of food from clones as being disproportionate
in terms of food safety and animal welfare, and said that, although
a temporary ban on the use of cloning techniques within the EU
would have little impact in the UK, as there are no companies
here currently offering a commercial cloning service, it was important
not to deny to UK industry technology which is available elsewhere
in the world, and which could be useful in bringing about more
rapid access to desirable traits, including resistance to disease.
3.5 We commented that, compared with
many similar documents, this was a well presented report, which
dealt in a balanced and sensible manner with a range of issues
arising on what is evidently a topic of undoubted public interest.
However, we noted the Government's reservations about aspects
of the immediate course of action proposed by the Commission,
and, in view of this, we recommended the report for debate in
European Committee A. That debate duly took place on 31 January
2011.
The current documents
3.6 The Commission has now brought forward
these two draft Directives, which would respectively:
· prohibit the commercial cloning
of traditionally farmed species (cattle, sheep pigs, goats and
horses), and the placing on the market of animal clones and embryo
clones (document (a)); and
· require Member States to
prevent food from animal clones from being placed on the market,
and to ensure that food of animal origin imported from third countries
where food from clones can be legally placed on the market or
is exported is only placed on the EU market where it can be established
that it does not derive from animal clones (document (b)).
3.7 However, the proposals will allow
the continuation of the use of reproductive material from clones
for livestock breeding purposes; for scientific research into
cloning and its use for the preservation of rare breeds or endangered
species; and for sporting or cultural events.
The Government's view
3.8 In his Explanatory Memorandum of
14 January 2014, the Parliamentary Under-Secretary of State at
the Department for Environment, Food and Rural Affairs (George
Eustice) says that the absence of any commercial cloning activity
in the UK (or EU) at present, means that a ban on the practice
will have no direct consequences for UK business. Addressing the
question of subsidiarity compliance, the Government does not believe
that either of the proposals is necessary, given the absence of
human health concerns associated with cloning and the protection
already offered by the existing EU animal welfare and novel foods
regime, but nevertheless considers that if there have to be controls
put in place, these must be done consistently at EU level.
3.9 The Minister adds that the available
science (including that from the European Food Safety Authority
(EFSA)) is clear that milk and meat from clones and their offspring
is no more harmful than that from traditionally reared animals,
and that, although the proposals aim to address welfare concerns
specifically surrounding the currently low efficacy of cloning,
and the resulting dam health complications and offspring mortality,
the Government believes — and the Commission acknowledges
— that the wellbeing of the animals concerned is already
generally protected by existing national and EU animal welfare
rules.
3.10 The Minister also observes that
the timing of the proposals is problematic, since they coincide
with negotiations between the EU and both the US and Mercosur
countries[25] concerning
bilateral trade agreements. He points out that these countries
already trade animal products freely, with no record of whether
they are derived from clones or not, and that, depending on the
final outcome of negotiations, the proposals could be tantamount
to a trade ban, and thus eventuality have significant repercussions
for both the EU and UK, who currently benefit from sizeable trade
flows in both directions, if (as seems likely) they give rise
to retaliatory action.
3.11 In addition, they would have the
potential to generate a challenge within the World Trade Organisation
(WTO) should the principles enshrined in the sanitary and phytosanitary
agreement be breached: and, since no records are kept of individual
cloning activity, the requirement to trace consignments of cloned
animals or cloned material would currently be impossible to enforce,
place significant regulatory and financial burdens on UK farmers,
food producers and taxpayers, and would not, in any case, address
the issue of products already present in the EU.
3.12 The Minister says that an EU Checklist
will be prepared once the relevant interested parties have consulted
on the detail of the proposals, and he hopes that this can be
made available by the beginning of July. However, he also comments
that, because of the particular sensitivities surrounding the
subject of cloning, neither the Commission nor the Greek Presidency
are expected to fast-track approval of the proposals, with discussions
at Council Working Group level not beginning until the end of
February. Also, given the impending European Parliament elections,
followed by the appointment of the new Commission, only limited
progress is expected before September 2014.
Legal issues
3.13 There are, additionally, several
legal issues on which the Minister comments. He identifies that
the proposals may interfere with the fundamental freedom to conduct
a business (Article 16 of the Charter). The Minister also says
that since the Government does not consider that the proposals
are necessary, it has some concerns that interference with the
right may be unwarranted. However, citing the Sky Österreich[26]
judgment and other ECJ cases, the Minister recognises that
the Court considers that a "broad range of reasons could
justify intereference right" and that it seemed likely that
"a Court would be receptive to the arguments presented by
the Commission".
3.14 The Minister also identifies that
as the legal base for document (b) is Article 352(1) TFEU, primary
legislation will be required before the UK Government can support
or approve the proposal pursuant to section 8 of the European
Union Act 2011.
Conclusion
3.15 It would appear that these proposals
mirror closely those canvassed in the report produced by the Commission
in 2010, which was debated in European Committee A in January
2011, and that — not surprisingly — the view taken
by the Government remains similar to that we reported to the House
on 24 November 2010. Consequently, although the subject of animal
cloning continues to be of some public interest, we do not see
any immediate need for a further debate (although we may well
do so at a later stage as the negotiations unfold, and the implications
— including those for the EU's bilateral trade agreements
— become clearer).
3.16 In the meantime, we think it
right to draw these proposals to the attention of the House,
but to hold them under scrutiny pending further developments,
including the preparation of an EU checklist (though we note that
only limited progress is expected before this autumn). We also
ask the Minister to respond, in time for consideration at our
meeting on 29 January, to the following points:
i) noting that the subsidiarity
deadline on both proposals is 17 February, how the Government
can conclude that EU level action is justified if it considers
legislative action is not necessary in the first place and therefore
that the pre-requisite for subsidiarity compliance is not met;
ii) whether the Government has
satisfied itself that the use of Article 352 TFEU by the Commission
in respect of document (b) is justified and the reasons for this;
and
iii) whether the Government has
considered the arguments relating to proportionality in concluding
that it is likely that the Court of Justice would not find the
proposed legislation was incompatible with Article 16 of the Charter
of Fundamental Rights.
22 Cloning is defined as replication by somatic cell
nuclear transfer to create genetic replicas. The report does
not cover embryo splitting or any form of genetic modification. Back
23
See (32117) 15277/10: HC 428-ix (2010-11), chapter 1 (24 November
2010). Back
24
These include the large number of cloned embryos which fail to
develop to term, the significant proportion which die during (or
shortly after) birth; the adverse on surrogate cattle dams; and
the tendency for cloned cattle and sheep to be unusually large. Back
25
Argentina, Brazil, Paraguay, Uruguay and Venezuela. Back
26
Case C-283/11 Sky Österreich, judgment of 22 January
2013, para 46. See also Case C-348/12P Kala Naft, judgment
of 28 November 2013, para 123; Case C-390/12 Pfleger, Advocate
General's Opinion, para 70. Back
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